Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 52
- Latest Decision
- 1980-09-16
Clearances · page 157 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K801751 | RAMI ULTRAVIOLET A BOOTH | Rami-Tan | LEJ | Class II | 1980-09-16 |
| K801991 | PLASTIC FORCEPS CAT.#1001-1010 | Pollak (Intl.), Ltd. | GEN | Class I | 1980-09-16 |
| K801996 | GUAZE BANDAGES CAT.#101-169 | Pollak (Intl.), Ltd. | NAB | Class I | 1980-09-16 |
| K801752 | RAMI TAN ULTRAVIOLET B BOOTH | Rami-Tan | LEJ | Class II | 1980-09-16 |
| K801543 | SUN VALLEY TANS | Sun Valley Tans, Inc. | LEJ | Class II | 1980-09-16 |
| K802021 | PEDIBAND CAT.#195-197 | Pollak (Intl.), Ltd. | NAD | Class I | 1980-09-16 |
| K801314 | VOCON MODEL VC526 | Teknar, Inc. | FSO | Class I | 1980-09-09 |
| K801840 | SURGICAL BANDAGES/SUNLEEP DX | Martin'S Maine Exchange | NAD | Class I | 1980-09-09 |
| K801995 | EYE PADS CAT.#581-599 | Pollak (Intl.), Ltd. | HMP | Class I | 1980-09-09 |
| K801637 | FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. | C.R. Bard, Inc. | KPK | Class II | 1980-08-27 |
| K801624 | SHARPLAN 723 CO2 LASER SURGICAL SYSTEM | Laser Industries , Ltd. | GEX | Class II | 1980-08-20 |
| K801864 | BARRIER APERTURED DRAPE | Surgikos, Inc. | KKX | Class II | 1980-08-20 |
| K801753 | ADT BONE MARROW BIOPSY-ASPIR. NEELDE | A.D.T. Lab Industries | GAA | Class I | 1980-08-20 |
| K801521 | CLASSIC TAN TANNING BOOTH | Classic Tan, Inc. | LEJ | Class II | 1980-08-20 |
| K801520 | SOLAR PACIFIC UVA SUNLAMP DEVICE | Solar Pacific | LEJ | Class II | 1980-08-20 |
| K801542 | SUNBED/SUNROOF OR SUNCOUCH/SUNSKY | Sunfit, Inc. | LEJ | Class II | 1980-08-20 |
| K801768 | CONTAIN X-RAY DETECTABLE LAP SPONGE | The Buckeye Cellulose Corp. | GDY | Class I | 1980-08-20 |
| K801819 | SURGICAL INSTRUMENTS | Robert I. Chien & Assoc., Inc. | HXD | Class I | 1980-08-20 |
| K801863 | BARRIER TOWEL DRAPE | Surgikos, Inc. | KKX | Class II | 1980-08-20 |
| K801759 | EFFRON PAROTID RETRACTOR | American V. Mueller | GAD | Class I | 1980-08-20 |
| K801746 | SUTURE REMOVAL PAK | Devco Medical Industries, Inc. | FZT | Class I | 1980-08-20 |
| K801823 | BAND-AID BRAND TRICOT MESH BANDAGES | Johnson & Johnson Professionals, Inc. | KGY | Class I | 1980-08-20 |
| K801766 | JACKSON-PRATT LARGE VOL. CLOSED WOUND | American Heyer Schulte | GCY | Class I | 1980-08-20 |
| K801737 | STERNUM SAW | Amsco Co. | KFK | Class I | 1980-08-20 |
| K801754 | ADT BONE MARROW ASPIRATION NEEDLE | A.D.T. Lab Industries | GAA | Class I | 1980-08-20 |
| K801824 | BAND-AID BRAND FLEXIBLE FABRIC BANDAGE | Johnson & Johnson Professionals, Inc. | KGY | Class I | 1980-08-20 |
| K801660 | PROXIMATE * PSD PURSE-STRING DEVICE | ETHICON, Inc. | GDJ | Class I | 1980-08-13 |
| K801349 | LOSEFF BALLOON TYPE SELF-RETENTION WOUND | Loseff Medical Designers, Ltd. | JCX | Class II | 1980-08-07 |
| K801065 | NIKKISO PARALLEL FLOW DIALYZERS | Int'L Marketing & Sales Corp. | FTG | Class II | 1980-08-07 |
| K801612 | FRAZIER-FERGUSON SUCTION TUBES (DISP.) | Edward Weck, Inc. | GCY | Class I | 1980-08-04 |
| K801590 | AUTO SUTURE DISPOSABLE GIA SURG. STAPLER | United States Surgical, A Division of Tyco Healthc | FHM | Class I | 1980-08-04 |
| K801617 | CONDUCTIVE SHOE COVERS | Procter & Gamble Mfg. Co. | FXP | Class I | 1980-08-04 |
| K801589 | AUTO SUTURE DISP. 30, ETC. & SURG. STAP | United States Surgical, A Division of Tyco Healthc | FHM | Class I | 1980-08-04 |
| K801610 | CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR | Edward Weck, Inc. | GCZ | Class I | 1980-08-04 |
| K800737 | DEBRISAN (DEXTRANOMER) PASTE | Pharmaseal Laboratories | KOZ | Class I | 1980-08-04 |
| K801555 | COMPACT MODEL 360 GALVANIC EPILATOR | Associated Electrolysis Group | KCW | Class I | 1980-08-04 |
| K801611 | DEEP BALFOUR BLADE FOR WILKINSON RETRACT | Edward Weck, Inc. | GAD | Class I | 1980-08-04 |
| K801680 | BETA-CAP II ADAPTER | Quinton, Inc. | GCE | Class I | 1980-08-04 |
| K801616 | NON-CONDUCTIVE SHOE COVERS | Procter & Gamble Mfg. Co. | FXP | Class I | 1980-08-04 |
| K801572 | SURG-ASSIST | Medmetric Corp. | FWZ | Class I | 1980-08-04 |
| K801429 | SUNSATION | Fashion, Inc. | LEJ | Class II | 1980-07-28 |
| K801570 | SHIELD DISP. PATIENTS PONCHO GOWNS | American Convertors Div., American Pharmaseal | FYB | Class II | 1980-07-28 |
| K801351 | EPILATOR, MODEL CP-16 | R. A. Fischer Co. Corp. | KCW | Class I | 1980-07-28 |
| K801341 | TAN YEAR ROUND SUN BED | Tan-Year Round, Inc. | LEJ | Class II | 1980-07-21 |
| K801095 | THE SUN BOOTH | Sun Booths , Ltd. | LEJ | Class II | 1980-07-21 |
| K801163 | SUNBURST, SUN SYSTEMS OR BC2 | Sun Ray Mfg., Inc. | LEJ | Class II | 1980-07-21 |
| K801350 | ACUVAC(TM) SUCTION RESERVOIR 400CC AND | Innovative Surgical Products, Inc. | GCY | Class I | 1980-07-14 |
| K801470 | MICRO CLIP STERILIZING CASE #65199 | Edward Weck, Inc. | FSM | Class I | 1980-07-14 |
| K801442 | P-S SURGICAL DRAIN | Pudenz-Schulte Medical Research Corp. | GCY | Class I | 1980-07-14 |
| K801443 | P-S SUCTION RESERVOIR | Pudenz-Schulte Medical Research Corp. | GCY | Class I | 1980-07-14 |
| K801444 | SKIN STAPLE REMOVER #523770 | Edward Weck, Inc. | GDT | Class I | 1980-07-14 |
| K801457 | ACCU-CORE DISPOSABLE BIOPSY NEEDLE | Medline Industries, Inc. | GAA | Class I | 1980-07-14 |
| K801353 | PARKE-DAVIS SURGICAL LIGHT | Warner-Lambert Co. | FTD | Class II | 1980-06-30 |
| K801382 | DISPOSABLE SURGICAL HEAD SUPPORT | Innovative Surgical Products, Inc. | FSE | Class I | 1980-06-26 |
| K801371 | ARGYLE VAC-U-CARE FLAT SILICONE WOUND T. | Sherwood Medical Co. | GCY | Class I | 1980-06-26 |
| K801372 | ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR | Sherwood Medical Co. | GCY | Class I | 1980-06-26 |
| K801436 | ORTHOPEDIC LOWER EXTREMITY SUSPENSION | Orthopedic Systems, Inc. | FYH | Class I | 1980-06-26 |
| K801374 | PROXIMATE (TMD) TISSUE MEASURING DEVICE | ETHICON, Inc. | FTY | Class I | 1980-06-26 |
| K801326 | ANSPACH OPERATING TABLE SUPPORT/SPINAL | The Anspach Effort, Inc. | EPW | Class I | 1980-06-26 |
| K801323 | HI-TEMP SURGICAL CAUTERY | Medical Products Development, Inc. | GEI | Class II | 1980-06-26 |
| K801043 | E-VAX CHEST DRAINAGE SYSTEM | Cardio Surgical Concepts, Inc. | JCX | Class II | 1980-06-20 |
| K801154 | PROXIMATE*(ILS) DISP. INTRALUMINAL STAP. | ETHICON, Inc. | GDW | Class II | 1980-06-20 |
| K801074 | STRAITH NASAL IMPLANT | Surgical Technology Laboratories, Inc. | FZE | Class II | 1980-06-17 |
| K801124 | NYLON LIGATING CLIP | ETHICON, Inc. | FZP | Class II | 1980-06-17 |
| K801017 | TANIT COMMERCIAL SUNTAN BOOTH | Tanit, Inc. | FTC | Class II | 1980-06-17 |
| K801072 | STRAITH NASAL SPLINT | Surgical Technology Laboratories, Inc. | FYI | Class I | 1980-06-17 |
| K801304 | CAMLOC SYRINGE BIOPSY KIT | Johannah Medical Services, Inc. | GEE | Class I | 1980-06-17 |
| K801329 | ANSPACH INSTRUMENT CADDY | The Anspach Effort, Inc. | HSZ | Class I | 1980-06-09 |
| K801328 | THE EQUALIZER | The Anspach Effort, Inc. | MDM | Class I | 1980-06-09 |
| K800744 | SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1 | Sun Ind., Inc. | LEJ | Class II | 1980-06-04 |
| K801036 | SURGICAL MASK | American Threshold Industries, Inc. | FXX | Class II | 1980-06-04 |
| K800950 | TANIT HOME SUNTANNING UNIT | Tanit, Inc. | FTC | Class II | 1980-06-04 |
| K800896 | WOLFF SYSTEM | Wolff System GmbH | LEJ | Class II | 1980-05-30 |
| K801025 | ODOR MASKING AGENT FOR CONTENTS OF ALL | The Buckeye Cellulose Corp. | FYA | Class II | 1980-05-30 |
| K801029 | CLINICAL DATA SYSTEM (CAM) MODULE | Adac Laboratories | LEJ | Class II | 1980-05-28 |
| K801058 | ILLUMINATED SPECULUM | Designs For Vision, Inc. | FXF | Class I | 1980-05-28 |
| K801162 | BARRIER PLUS SURGEON GOWNS | American Hospital Supply Corp. | FYC | Class II | 1980-05-23 |
| K801158 | NDM DIATEMP ELECTROSURGICAL DIS. PAD | Ndm Corp. | GEI | Class II | 1980-05-23 |
| K801153 | VALLEYLAB RETURN ELECTRODE MONITOR | Valleylab, Inc. | GEI | Class II | 1980-05-20 |
| K801075 | STRAITH CHISEL FORCEPS | Surgical Technology Laboratories, Inc. | GEN | Class I | 1980-05-20 |
| K801069 | STERILE ISOLATION GOWN | Medspec Corp. | FYC | Class II | 1980-05-20 |
| K801033 | STERILE DRAPE 17X18 W/3 FENESTRATION | Veratex Corp. | KKX | Class II | 1980-05-20 |
| K800809 | FLARE DIS. CONDUCTIVE&NON. SHOE COVERS | Flare Products, Inc. | FXP | Class I | 1980-05-20 |
| K800953 | FIXOMULL STERILE | Beiersdorf, Inc. | NAD | Class I | 1980-05-20 |
| K801028 | RICA OR SMIC SURGICAL INSTRUMENTS | Robert I. Chien & Assoc., Inc. | HXD | Class I | 1980-05-20 |
| K800928 | WHITE KNIGHT SUPPLEMENTAL DRAPE | G.D. Searle and Co. | KKX | Class II | 1980-05-20 |
| K801132 | BOUNDARY EXTREMITY DRAPE | Procter & Gamble Mfg. Co. | KKX | Class II | 1980-05-20 |
| K800933 | R2 ELECTROSURG. RETURN ELECT. #225ETC. | R2 Corp. | JOT | Class II | 1980-05-20 |
| K801032 | STERILE DRAPE 17X18 CODE D-6A | Veratex Corp. | KKX | Class II | 1980-05-20 |
| K801068 | STERILE ABDOMINAL PAD | Medspec Corp. | KKX | Class II | 1980-05-20 |
| K800927 | WHITE KNIGHT DISP. STERILE BACK GOWN | G.D. Searle and Co. | FYA | Class II | 1980-05-20 |
| K801073 | STRAITH CHIN IMPLANTS | Surgical Technology Laboratories, Inc. | FWP | Class II | 1980-05-20 |
| K800810 | FLARE DIS. NONWOVEN HEAD COVERS | Flare Products, Inc. | FYF | Class I | 1980-05-20 |
| K800929 | WHITE KNIGHT SURGICAL PACK | G.D. Searle and Co. | FYA | Class II | 1980-05-20 |
| K800382 | CLEAR-VIEW MIRROR WARMER | Surgical Mechanical Research, Inc. | GET | Class I | 1980-05-14 |
| K800617 | HYFRECATOR, #733 | Birtcher Corp. | GEI | Class II | 1980-05-02 |
| K800817 | SHIELD DISP. REINFORCED DRAPE SHEETS | American Convertors Div., American Pharmaseal | KKX | Class II | 1980-05-02 |
| K800278 | MEDSPEC SAFETY PINS | Medspec Corp. | KKX | Class II | 1980-05-02 |
| K800414 | ADT SOFT TISSUE BIOPSY TRAY | A.D.T. Lab Industries | GAA | Class I | 1980-04-28 |
| K800418 | ADT DISPOSABLE THIN NEEDLE ASPIRATION | A.D.T. Lab Industries | FSM | Class I | 1980-04-28 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.